Participant Information Sheet
Research Study Title: PRIME Pilot study
We would like to invite you to take part in our research study. Before you decide, we
would like you to understand why the research is being done and what it would
involve for you. A member of the research team will go through the information sheet
with you and answer any questions you have. Talk to friends and relatives about the
study if you wish.
This information sheet is divided into two parts. Part 1 discusses the purpose of the
study. Part 2 gives more detailed information about the conduct of the study
Part 1
What is the purpose of the PRIME Pilot study?
The purpose of this research project is to look at a promising new way of improving
how people are looked after when they have major abdominal surgery. Although
surgery is much safer than it was as little as 20 years ago, patients having major
surgery remain at risk of complications. We continue to look for ways to reduce these
problems.
The new treatment is called RIPC (see below). It has been shown that this treatment
improves the heart’s ability to withstand the stress of surgery in several other
specialties, notably in heart surgery, head & neck surgery, and major artery surgery.
No one has looked at this treatment in abdominal surgery, and we want to trial it to
see if it would be useful for this group of patients too.
Heart muscle damage is a good indicator of the stress it experiences during surgery.
We want to measure heart muscle damage using blood tests, as this is an extremely
sensitive way of detecting this type of injury.
What is PRIME and RIPC?
PRIME stands for Perioperative Reduction in Inapparent Myocardial Events.
Essentially, this means looking at a way of reducing heart muscle damage, with or
without symptoms, in the period during and immediately after surgery. As you would
expect, studies have shown that any heart muscle damage is bad for patients in the
long-term, whether they have symptoms of heart damage, or not (i.e. when only
blood test can detect it).
RIPC stands for Remote Ischaemic Pre-Conditioning. This is the new treatment we
want to test. Again, previous studies have shown that briefly reducing the blood
supply to one part of the body, for example an arm or a leg, leads to a release of
special chemicals that protect other areas of the body from similar reductions in
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blood supply. An example of this is in heart surgery, where one study showed that
reducing the blood supply to an arm briefly before an operation halved the amount of
damage sustained by the heart because of reduced blood flow. We know that the
heart can be damaged in all types of surgery, and therefore, we want to see whether
this treatment works in our patients too, namely those having major bowel surgery. In
our study, RIPC will be done by simply inflating a blood pressure cuff on your arm
three times, just before the operation starts.
Why have I been invited?
You have been invited to participate because your planned abdominal operation is of
the sort that we believe will benefit from this treatment. It is important to remember
that participation in the research is entirely voluntary. It is up to you to decide to join
the study. We will describe the study and go through this information sheet. If you
agree to take part, we will then ask you to sign a consent form. You are free to
withdraw at any time, without giving a reason. This would not affect the care you
receive in any way.
Part 2
What will happen to me if I take part?
If you agree to take part in the study, we will ask you to sign a consent form to say
you have given your permission to be included. Before your planned operation, we
will collect some information about your medical history, and take a blood test (this
will be at the same time as your usual pre-operative blood test). We will then
randomly assign you to either having the treatment or not having the treatment
(allocating randomly like this allows us to look for differences to show if the treatment
works).
On the day of the operation, you will meet the surgeon and the anaesthetist as usual.
A member of the research team will also meet you to see if you have any further
questions. After you are put to sleep at the start of the operation, if you have been
selected to have the treatment, a blood pressure cuff will be inflated on one of your
arms 3 times, for 5 minutes each. Then you will have your surgery as usual. If you
are not selected to have the treatment, you will be held in the anaesthetic room for
the same time only. After this period, you will have your operation as usual.
After the operation, we will take blood samples from you for the first three days to
look for heart muscle damage. We will try to synchronise this with your usual postoperative blood tests. All other aspects of your post-operative care will be the same.
At discharge, we will review your notes to see if you had any unexpected problems.
Then, about a month after the operation, we will see you in clinic or call you to see
how you are getting on.
What are the possible risks of taking part?
This is a very low risk treatment. You will normally have a blood pressure cuff inflated
on you arm several times throughout your surgery, but normally for 1-2 minutes
instead of 3 sets of 5 minutes. This additional time is not expected to cause any
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noticeable ill effects. All of the studies performed so far have not reported any
problem with this treatment. Equally, the additional time spent under anaesthetic
because of the treatment will be small and is very unlikely to cause ill effect. Lastly,
we will try to synchronise the additional blood samples with your normal postoperative blood tests, to keep the overall number of tests as close to normal as
possible.
What if want to withdraw?
You can withdraw at anytime in the study, while we can identify your data. This will
remain the case until the last patient has finished their participation
Who is organising and funding this research, and who has reviewed the study?
This study has been designed and organised by member of the general surgical and
intensive care teams. It has been reviewed by the Berkshire Ethics committee, who’s
main role is to safeguard and protect your interests. Furthermore, our study has been
independently reviewed by experts in the field to ensure its scientific rigour. It is paid
for by a private local fund to assist small-scale projects such as this one.
I have some more questions, with whom may I get in contact?
In the first instance, please direct your questions to the main investigator for the trial
Mr Stefan Antonowicz, at stefan.antonowicz@royalberkshire.nhs.uk or through the
main hospital switchboard, bleep 526.
In the second instance, the Royal Berkshire R&D office can be contacted at Physio
East, Level 2, Royal Berkshire Hospital, London Road, reading, Berkshire, RG1 5AN,
Tel:01183228693, Fax: 01183228425
Finally, the Patient Advice and Liaison Service can be contacted on Tel:0118 322
8338, or at talktous@royalberkshire.nhs.uk
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Consent Form
Research Study Title: PRIME Pilot study
Participant Details
Surname
First name
Date of Birth
Hospital No
Statement of Participant
Please initial box
I confirm that I have read and understood the information sheet (version
1.2) for the PRIME Pilot study. I have had an opportunity to ask questions
about what is involved, and I they have been answered satisfactorily.
I understand that my participation is voluntary and that I am free to
withdraw at any time without giving any reason, without my medical care
or legal rights being affected.
I agree to extra blood tests after the operation, although this number is
likely to be small. I agree to allow samples to be used in related research
after this study has concluded.
I understand that authorised researchers from this study may look at
relevant sections of my medical notes and data collected during the study.
I give permission for these individuals to have access to my records. I
understand that all data will be confidential and anonymous and destroyed
5 years after the study ends.
I agree to take part in the PRIME Pilot study.
Signature of Patient
Print name
Date
Signature of Person Taking Consent
Print name
Date
Copy to be given to the participant. Copy in medical notes and original to Mr Stefan
Antonowicz, SpR, Department of Surgery, Royal Berkshire Hospital, Bleep: 526
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